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Telemonitoring and Quality of Life in Patients after 12 Months Following a Pacemaker Implant: the Nordland Study, a Randomised Trial.

ABSTRACT: The purpose of this study was to analyse the health-related quality of life (HRQoL) of patients followed up using a remote device-monitoring system (TM) compared to patients followed up through standard outpatient visits (HM), 12 months after the implantation of a pacemaker. This was a trial design that used the EuroQol-5D Questionnaire and the Minnesota Living with Heart Failure Questionnaire (MLHF). The HRQoL of a cohort of 50 consecutive patients randomly allocated to one of the two follow-up modalities was measured at baseline and then during follow-up, 12 months after the pacemaker implantation. Eventually, 23 patients were followed-up through standard outpatient visits, while 23 used a remote monitoring system. Results: The baseline clinical characteristics and health-related quality of life of the patients from both groups were observed to be statistically similar. Twelve months after the pacemaker implantation, both groups showed statistically significant improvements in the baseline parameters based on the MLHF. The patients followed up through hospital visits showed a greater increase in MLHF-HRQoL after 12 months, although the increase was not significantly greater than that of the TM group. Furthermore, the frequencies of emergency visits and re-hospitalisations did not differ between the groups.

SUBMITTER: Lopez-Liria R

PROVIDER: S-EPMC6603952 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Telemonitoring and Quality of Life in Patients after 12 Months Following a Pacemaker Implant: the Nordland Study, a Randomised Trial.

López-Liria Remedios R López-Villegas Antonio A Enebakk Terje T Thunhaug Hilde H Lappegård Knut Tore KT Catalán-Matamoros Daniel D

International journal of environmental research and public health 20190605 11

The purpose of this study was to analyse the health-related quality of life (HRQoL) of patients followed up using a remote device-monitoring system (TM) compared to patients followed up through standard outpatient visits (HM), 12 months after the implantation of a pacemaker. This was a trial design that used the EuroQol-5D Questionnaire and the Minnesota Living with Heart Failure Questionnaire (MLHF). The HRQoL of a cohort of 50 consecutive patients randomly allocated to one of the two follow-up ...[more]

PMID: 31195650

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Project description:BackgroundThe concept of 'patient experience' has become central to how to improve healthcare. Remote communication with patients is today a frequent practice in healthcare services, showing similar outcomes to standard outpatient care while enabling cost reduction in both formal and informal care. The purpose of this study was to analyse the experiences of people with telemonitoring pacemakers.MethodsPatients were randomly allocated to either the telemonitoring or hospital monitoring follow-ups. Using the 'Generic Short Patient Experiences Questionnaire' (GS-PEQ), as well as an ad-hoc survey from the 'telehealth patient satisfaction survey' and 'costs survey', patients' experiences were measured six months after the pacemaker implant in a cohort of 50 consecutive patients. The mean age was 74.8 (± 11.75) years and 26 (52%) patients were male of which 1 was lost in follow-up. Finally, 24 patients were followed up with standard hospital monitoring, while 25 used the telemonitoring system. Differences in baseline characteristics between groups were not found.ResultsFindings showed overall positive and similar experiences in patients living with telemonitoring and hospital monitoring pacemakers. Significant differences were found in GS-PEQ concerning how telemonitoring patients received less information about their diagnosis/afflictions (p = 0.046). We did not find significant differences in other items such as 'confidence in the clinicians' professional skills', 'treatment perception adapted to their situation', 'involvement in decisions regarding the treatment', 'perception of hospital organisation', 'waiting before admission', 'satisfaction of help and treatment received', 'benefit received', and 'incorrect treatment'.ConclusionsThe remote communication of pacemakers was met with positive levels of patients' experiences similarly to patients in the hospital monitoring follow-up. However, telemonitoring patients received less information. Thus, improving the quality and timing of information is required in telemonitoring patients in the planning and organisation of future remote communication healthcare services for people living with a pacemaker implant.

Project description:BACKGROUND:With an ageing population and widening indications for pacemakers implantation, the number of persons carrying an implant is steadily increasing. The routine follow-up is thus a heavy burden for the respective NHS as well as for the patients and their relatives. Most of them of the studies have been performed in densely populated areas and nearby to the hospital. It is thus unknown whether these results could be applied also in rural areas such as Northern Norway with a more scattered population. The aim of this study was to assess the effectiveness of tele-monitoring (TM) in patients with pacemakers regarding reliability, safety and health-related quality of life, compared to traditional follow-up in outpatient clinic in a setting where geographical effects could possible influence the results. METHODS:The NORDLAND study is a controlled, randomized, non-masked clinical trial in pacemaker patients, with data collection carried out during the pre-implant stage and after 6 months. Between August of 2014 and November of 2015, 50 patients were assigned to either a tele-monitoring group (n =?25) or a conventional hospital monitoring (HM) group (n =?25). The EuroQol-5D (EQ-5D) utilities and visual analogue scale (VAS) and the Minnesota Living with Heart Failure Questionnaire (MLHFQ) were used to measure Health-Related Quality of Life. Baseline characteristics and number of hospital visits were also analyzed. RESULTS:The baseline characteristics of the two study groups were similar for EQ-5D utilities (TM:0.81; HM:0.76; p =?0.47), EQ-5D VAS (TM: 64.00; HM:64.88; p =?0.86) and the MLHFQ (TM:20.20; HM:28.96; p =?0.07). At the 6 month follow-up, there were no significant differences between the groups in EQ-5D utilities (TM: 0.81; HM: 0.76; p =?0.54) and EQ-5D VAS scores (TM: 72.71; HM: 59.79; p =?0.08). The MLHFQ score was improved in both groups (TM: -4.40; HM: -15.13; p <? 0.001). The number of in-office visits was similar in both groups (TM: 1.24 vs HM: 1.12; P = 0.30). CONCLUSIONS:The NORDLAND trial shows that HRQoL is improved after implant in both groups. Without significant differences with regards to effectiveness and safety. In addition, provides a scientifically rigorous method to the field of HRQoL evaluations in patients with pacemakers. TRIAL REGISTRATION:ClinicalTrials.gov NCT02237404 , September 11, 2014.

Project description:(1) Introduction: In the last two decades, telemedicine has been increasingly applied to telemonitoring (TM) of patients with pacemakers; however, presently, its growth has significantly accelerated because of the COVID-19 pandemic, which has pushed patients and healthcare workers alike to seek new ways to stay healthy with minimal physical contact. Therefore, the main objective of this study was to update the current knowledge on the differences in the medium-and long-term effectiveness of TM and conventional monitoring (CM) in relation to costs and health outcomes. (2) Methods: Three databases and one scientific registry were searched (PubMed, EMBASE, Scopus, and Google Scholar), with no restrictions on language or year of publication. Studies published until July 2021 were included. The inclusion criteria were: (a) experimental or observational design, (b) complete economic evaluation, (c) patients with implanted pacemakers, and (d) comparison of TM with CM. Measurements of study characteristics (author, study duration, sample size, age, sex, major indication for implantation, and pacemaker used), analysis, significant results of the variables (analysis performed, primary endpoints, secondary endpoints, health outcomes, and cost outcomes), and further miscellaneous measurements (methodological quality, variables coded, instrument development, coder training, and intercoder reliability, etc.) were included. (3) Results: 11 studies met the inclusion criteria, consisting of 3372 enrolled patients; 1773 (52.58%) of them were part of randomized clinical trials. The mean age was 72 years, and the atrioventricular block was established as the main indication for device implantation. TM was significantly effective in detecting the presence or absence of pacemaker problems, leading to a reduction in the number of unscheduled hospital visits (8.34-55.55%). The cost of TM was up to 87% lower than that of CM. There were no significant differences in health-related quality of life (HRQoL) and the number of cardiovascular events. (4) Conclusions: Most of the studies included in this systematic review confirm that in the TM group of patients with pacemakers, cardiovascular events are detected and treated earlier, and the number of unscheduled visits to the hospital is significantly reduced, without affecting the HRQoL of patients. In addition, with TM modality, both formal and informal costs are significantly reduced in the medium and long term.

Project description:PurposeThe aim of this study was to explore and describe quantitatively patient-reported outcome measures (PROMs), ie, health-related quality of life (QoL), visual function and treatment satisfaction, in patients with diabetic macular edema (DME) receiving two different regimens of Ozurdex (intravitreal dexamethasone implant).MethodsIn this multicenter, prospective study, 100 patients with center-involving refractory DME were randomized 1:1 to either five monthly fixed dosing or optical coherence tomography (OCT)-guided pro re nata (PRN) regimen of dexamethasone intravitreal implant therapy. The primary outcome was the difference between arms in change in PROMs and health-related QoL from baseline to 12 months, as measured by the Retinopathy-Dependent Quality of Life (RetDQoL) questionnaire, Visual Function Questionnaire-25 (VFQ-25) and Retinopathy Treatment Satisfaction Questionnaire (RetTSQ).ResultsThere was no statistically significant difference in the RetDQoL score and VFQ-25 score at month 12 compared to those at baseline, whereas the total mean RetTSQ score increased significantly at the exit visit. The two treatment arms did not differ significantly regarding the change in PROMs and health-related QoL questionnaires. Logistic regression analysis showed that visual acuity (VA) of ≥55 letters, central foveal thickness <300 μm and macular volume <9.2 mm3 at the exit visit (month 12) predicted a higher change in RetTSQ.ConclusionThis study showed that there is a statistically significant improvement in treatment satisfaction, as measured by RetTSQ, in patients with DME treated with dexamethasone intravitreal implant, independent of the dose regimen, namely, fixed or PRN. However, it should be noted that the clinically meaningful change could not be assessed accurately, since no thresholds for clinically meaningful change currently exist for the RetTSQ. On the other hand, there was no significant change in health-related QoL, as measured using VFQ-25 and RetDQoL. Factors affecting the patients' treatment satisfaction were the final VA, the central foveal thickness and the macular volume.

Project description:INTRODUCTION:The aim of our study was to perform an economic assessment in order to check whether or not telemonitoring of users with pacemakers offers a cost-effective alternative to traditional follow-up in outpatient clinics. METHODS:We used effectiveness and cost data from the NORDLAND trial, which is a controlled, randomized, non-masked clinical trial. Fifty patients were assigned to receive either telemonitoring (TM; n = 25) or conventional monitoring (CM; n = 25) and were followed up for 12 months after the implantation. A cost-utility analysis was performed in terms of additional costs per additional Quality-Adjusted Life Year (QALY) attained from the perspectives of the Norwegian National Healthcare System and patients and their caregivers. RESULTS:Effectiveness was similar between alternatives (TM: 0.7804 [CI: 0.6864 to 0.8745] vs. CM: 0.7465 [CI: 0.6543 to 0.8387]), while cost per patient was higher in the RM group, both from the Norwegian NHS perspective (TM: €2,079.84 [CI: 0.00 to 4,610.58] vs. €271.97 [CI: 158.18 to 385.76]; p = 0.147) and including the patient/family perspective (TM: €2,295.91 [CI: 0.00 to 4,843.28] vs. CM: €430.39 [CI: 0.00 to 4,841.48]), although these large differences-mainly due to a few patients being hospitalized in the TM group, as opposed to none in the CM group-did not reach statistical significance. The Incremental Cost-Effectiveness Ratio (ICER) from the Norwegian NHS perspective (€53,345.27/QALY) and including the patient/caregiver perspective (€55,046.40/QALY), as well as the Incremental Net Benefit (INB), favors the CM alternative, albeit with very broad 95%CIs. The probabilistic analysis confirmed inconclusive results due to the wide CIs even suggesting that TM was not cost-effective in this study. Supplemental analysis excluding the hospitalization costs shows positive INBs, whereby suggesting a discrete superiority of the RM alternative if hospitalization costs were not considered, albeit also with broad CIs. CONCLUSIONS:Cost-utility analysis of TM vs. CM shows inconclusive results because of broad confidence intervals with ICER and INB figures ranging from potential savings to high costs for an additional QALY, with the majority of ICERs being above the usual NHS thresholds for coverage decisions. TRIAL REGISTRATION:ClinicalTrials.gov NCT02237404.

Dataset Information

Telemonitoring and Quality of Life in Patients after 12 Months Following a Pacemaker Implant: the Nordland Study, a Randomised Trial.

Publications

Telemonitoring and Quality of Life in Patients after 12 Months Following a Pacemaker Implant: the Nordland Study, a Randomised Trial.

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